Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia

Wyeth is now a wholly owned subsidiary of Pfizer430 enrolled

Overview

To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

430

Conditions

Bacterial Pneumonia

Interventions

TigecyclineDRUG

ImipenemDRUG

CilastatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subjects over 18 years of age. Bulgaria Only: Male or female subjects over 18 years of age and under 70 years of age. * Subjects known or suspected to have acute hospital-acquired pneumonia. Exclusion Criteria: * Presence of any of the following pulmonary conditions: cystic fibrosis; pulmonary malignancy (either primary or metastatic); known bronchial-obstructive or post obstructive pneumonia; pulmonary abscess; empyema; known or suspected active tuberculosis; bronchiectasis; sarcoidosis; known or suspected pulmonary infection caused by Pneumocystis carinii, mycobacteria, fungi, parasites, or viruses (Subjects with COPD are not excluded) * Suspected or known Legionella infection * Concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis

Locations (29)

Unnamed facility

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

The co-primary efficacy endpoints are clinical response at the TOC assessment for the clinically evaluable population and the clinical modified intent-to-treat population.

Data from ClinicalTrials.gov

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